Device and instrument for treatment of elevated intraocular pressure

ABSTRACT

Apparatus for relieving intraocular pressure in an eye of a subject that includes a plurality of stents, a delivery vehicle for inserting the stents together through a single incision in the cornea of the eye to a position in the anterior chamber adjacent to the trabecular meshwork and an actuator that can be activated from outside of the eye for pushing the stents out of the delivery vehicle and into a plurality of anatomical spaces in the eye from which aqueous from the anterior chamber can be drained. Also, methods for use of the apparatus for controlling the flow of aqueous from the anterior chamber.

CROSS-REFERENCE TO RELATED APPLICATION

This is a divisional of copending application Ser. No. 15/998,977 filedon Aug. 7, 2018, which claims priority under 35 U.S.C. § 119(e) to U.S.Patent Application No. 62/546,972 filed on Aug. 17, 2017, the disclosureof which in is incorporated by reference herein in its entirety.

BACKGROUND OF THE INVENTION

Glaucoma is a condition whereby the optic nerve is damaged as aconsequence of intraocular pressure elevation above the threshold whichthe optic nerve tolerates. Reducing intraocular pressure is presentlythe only treatment for slowing the rate of progression of thisglaucomatous optic nerve damage. Multiple medical and surgical methodshave been employed for lowering intraocular pressure. The medicaltreatment of glaucoma relies on the use of eye drops which reduce theamount or rate of aqueous humor (the fluid filling the eye) producedwithin the eye. A further mechanism for lowering intraocular pressure isincreasing the outflow of aqueous fluid from the eye which can beaccomplished with eye drops or oral medications. The use of topical andsystemic (oral) medications have significant side effects which alterthe ocular surface, periocular tissues and the interior structures ofthe eye, as well as affecting the overall health of the patient.Surgical methods also have been described which lower intraocularpressure by producing new outflow channels, or modifying existingoutflow channels, or by selectively altering or destroying the fluidproducing part of the eye (ciliary processes).

Heretofore the majority of these surgical procedures resulted insignificant structural alteration to the eye. Surgical manipulation ofthe ocular surface in the course of performing surgery for glaucoma istraumatic. The most effective procedures require incising and dissectingthe conjunctival, episcleral, and scleral tissues, cautery of the ocularsurface, scleral dissection, and removal of iris, trabecular and scleraltissues. The use of sutures to close the surgical wound to close thesewounds induce significant inflammation. The resultant complexity andvariability in technique make the procedures artisanal. Due to thedifficulty in performing the procedures, and their attendant requirementfor intensive postoperative care, a minority of ophthalmic surgeonsperform these procedures. The reduced safety profile, inconsistentoutcomes and lack of efficacy have led to the introduction of newerprocedures.

Recently, multiple medical devices have been introduced which seek toreduce the damage to the ocular structures responsible for fluidproduction and outflow. The goal of these minimally or micro-invasiveglaucoma surgeries (MIGS) is increased safety with efficacy comparableto the existing mainstays of glaucoma surgery (trabeculectomy, glaucomadrainage implants, cyclodestruction). These newer procedures increasethe surgical armamentarium of eye surgeons and while less effective,have made these procedures surgeries safer than older procedures. Forpatients with significant glaucoma, MIGS are, at present, not preferredby most glaucoma specialists.

The newer procedures include new methods for implanting glaucomadrainage implants. These implants may be implanted using an ab externoapproach (entering through the conjunctiva and inwards through thesclera into the interior of the eye) or an ab interno approach (enteringthrough the cornea, across the anterior chamber, and drainage tissues ofthe the eye, trabecular meshwork, Schlemm's canal, supra-choroidal andsubconjunctival space). Traditional ab externo approaches are shown forexample in U.S. Pat. No. 8,109,896 to Nissan et al., U.S. Pat. No.8,075,511 to Tu et al., and U.S. Pat. No. 7,879,001 to Haffner et al.,the contents of each of which is incorporated by reference herein in itsentirety. Conventional ab interno approaches and devices for usetherewith are shown, for example in U.S. Pat. No. 6,007,511 to Prywes,U.S. Pat. No. 6,544,249 to Yu, et al., U.S. Pat. App. Pub. No. US2008/0108933 A1 to Yu, et al., etc, the contents of each of which isincorporated by reference herein in its entirety.

The traditional ab externo approaches involve surgery in which theconjunctiva, sclera, and sometimes the trabecular meshwork are openedfrom outside-in. This surgery is not minimally invasive. Methods forplacing an implant ab interno, or ab externo are available. Methods forab interno implantation require an apparatus that can deliver an implantthrough the cornea and across the anterior chamber into a suitableposition preferably with one, and only one, incision in the cornea.

Existing procedures for glaucoma surgery, including classictrabeculectomy, tube-shunt devices (Ahmed®, Baerveld, Molteno®) andciliodestructive (Cyclophotocoagulation (CPC), endocylcophotocoagulation(ECP)) and Micro (Minimally) Invasive Glaucoma Surgery (MIGS), aredesigned to provide treatment of one outflow channel (e.g., CPC) ordevice (e.g., iStent®, Cypass®, XEN®). Heretofore, ab interno glaucomasurgeries have targeted the outflow channels in the trabecular meshwork,suprachoroidal space, and the subconjunctival space where collectorlymphatics drain fluid from the eye. Cyclodestructive procedures haveselectively altered or destroyed the fluid producing tissues in theciliary body.

Ab interno MIGS procedures presently have heretofore focused onindividual outflow pathways. For example, the iStent® (Glaukos) targetsthe outflow channel of Schlemm's canal by inserting a snorkel-likedevice which bypasses the trabecular meshwork. This procedure and adevice for performing the same is described, for example, in U.S. Pat.No. 6,638,239 to Bergheim, et al., U.S. Pat. No. 6,736,791 to Tu, etal., and U.S. Pat. App. Pub. No. 2005/0271704 to Tu, et al. the contentsof each of which are incorporated herein by reference in its entirety.This procedure has been successful for intraocular pressure (IOP)lowering where only mild to moderate reduction is required. It has beenused as an adjunct to cataract surgery in most patients with (topical ororal) medications or other surgical procedures being required forfurther IOP reduction. In the United States, the iStent® is onlyapproved in conjunction with cataract surgery since it is notsufficiently effective in lowering IOP when performed without cataractsurgery.

The CyPass® procedure seeks to use the uveoscleral outflow channels ofthe suprachoroidal space, and with mild to moderate IOP reduction, alsoonly with concomitant cataract surgery due to reduced efficacy. Thisprocedure and a device for use therewith is described, for example, inU.S. Pat. App. Pub. No. 2014/0163448 A1 to Lind, et al., the contents ofeach of which are incorporated herein by reference in its entirety.

The XEN® gel stent has recently been approved for refractory glaucomaand may be performed without cataract surgery. This procedure and adevice for use therewith is described, for example, in U.S. Pat. No.9,017,276 to Horvath, et al., the contents of each of which areincorporated herein by reference in its entirety. The device bypassesthe trabecular meshwork, Schlemm's canal, and sclera draining aqueousfluid into the subconjunctival space. It is non-inferior totrabeculectomy regarding efficacy, while allowing greater safety. Theshort-term results of all of these MIGS surgeries is promising. However,even with mild to moderate reduction of IOP initially there isfrequently a need for further intraocular pressure lowering orintervention while continuing to minimize the complexity of glaucomasurgery.

Heretofore devices which drain into the subconjunctival space have beennoted to develop a fibrotic capsule around the ostium (XEN® gel stent)or drainage plate surface (Molteno®, Baerveldt, Ahmed®). Subconjunctivalscarring around the devices requires intervention in a significantnumber of patients. This reduces their effectiveness in loweringintraocular pressure. The production of inflammatory cytokines in theaqueous is the mechanism demonstrated by Epstein and Freedman, occurringprior to, or soon after, these surgical procedures.

Temporarily obstructing the ostium of the subconjunctival tube in thelarger drainage devices has been proven to reduce the fibrosis aroundthe plate of the larger drainage devices. Means for temporarilyobstructing the ostium of subconjunctival tubes are described, forexample, in the following US patent publications: U.S. Pat. No.7,655,831 to Prywes, U.S. Pat. No. 5,346,464 to Camras, the contents ofeach of which are incorporated herein by reference in its entirety.

Unfortunately, a possible consequence of temporarily obstructing theprior art devices includes marked elevation of IOP, and consequentworsening of glaucoma. Sudden lowering of IOP when the tube occlusion isreleased may result in significant complications including choroidaleffusion, hypotony (severe IOP reduction), bleeding and visual loss. Toprevent these complications additional surgical measures have beenrequired. A temporarily functioning trabeculectomy (orphantrabeculectomy), and tube venting punctures (slits), are usuallyemployed to mitigate the problems of IOP elevation and subsequenthypotony, but often are not completely effective until the tube opens.Frequently oral medications (acetazolamide) and multiple topicalmedications are employed and only partially effective in maintainingsafety.

There is thus a need for improved apparatus and methods for treatment ofelevated intraocular pressure to prevent the above and othercomplications from glaucoma surgery.

SUMMARY OF THE INVENTION

The inventor has developed improved devices to deliver and insertimplants into the eye of a patient for treatment of elevated intraocularpressure, which devices can be used in ab interno procedures, or in bothab interno and ab externo procedures. These devices have a number ofadvantages over prior art devices, including that they are insertablethrough a single incision in the cornea and, in one embodiment, can beused to attack multiple loci of the same outflow pathway (e.g.,subconjunctival space, Schlemm's Canal or suprachoroidal space) and, inanother embodiment, can be used to attack single or multiple loci ofmultiple outflow pathways (e.g., Schlemm's Canal, suprachoroidal, andsubconjunctival space). These devices can be used to make MIGS moresuccessful while reducing complications. For example, with multiplechannels for outflow of aqueous from the anterior chamber, or withmultiple outflow pathways of aqueous from the anterior chamber, it ispossible to obstruct a single channel or pathway temporarily, therebyreducing inflammatory cytokine outflow and subsequent fibrosis around anoutflow port with reduced risk of marked elevation or severe reductionof IOP in the anterior chamber.

In accordance with a first embodiment of the invention, there isprovided an apparatus for relieving intraocular pressure in an eye of asubject comprising:

(a) a plurality of stents, including at least (i) a first stent sizedand configured for being implanted in the eye through a hole in a firstmembrane separating a high pressure chamber of the eye from a firstanatomical space of lower pressure than the high pressure chamber in afirst disposition with an inlet end of the first stent in the highpressure chamber and an outlet end of the first stent in the firstanatomical space to permit drainage of fluid from the high pressurechamber to the first anatomical space and with a portion of the firststent engaging with the first membrane to stabilize and retain the firststent in the first disposition, and (ii) a second stent sized andconfigured for being implanted in the eye through a hole in a secondmembrane separating the high pressure chamber of the eye from a secondanatomical space of lower pressure than the high pressure chamber in asecond disposition with an inlet end of the second stent in the highpressure chamber and an outlet end of the second stent in the secondanatomical space to permit drainage of fluid from the high pressurechamber to the second anatomical space and with a portion of the secondstent engaging with the second membrane to stabilize and retain thesecond stent in the second disposition; wherein the high pressurechamber is the anterior chamber of the eye, and wherein each of thefirst and second anatomical spaces is selected from the group consistingof a subconjunctival space, Schlemm's canal and a suprachoroidal space,wherein the first anatomical space and the second anatomical space canbe different areas of the same anatomical space;

(b) delivery means for releasably carrying at least the first stent andthe second stent together through a single incision in the cornea of theeye to a first position in the anterior chamber of the eye that isadjacent the trabecular meshwork and for holding the first and secondstents at said position in an anterior to posterior configuration untilthe first and second stents are released from the delivery means, thedelivery means comprising means for forming respective holes in thefirst and second membranes through which the first and second stents areinsertable or each of the first and second stents comprising a sharpenedend for forming respective holes in the first and second membranesthrough which the first and second stents are respectively insertable;the first and second stents being disposed in the delivery means andbeing respectively sized and configured such that, with the deliverymeans in the first position and with application of a force to each ofthe first and second stents, each of the first and second stents isreleasable from the delivery means and implantable into the eye throughthe respective holes formed in the first and second membranes and intothe first and second dispositions respectively; and

(c) actuating means for applying a force to each of the first and secondstents to cause the first and second stents to be released from thedelivery means and implanted into the eye with the first and secondstents in the first and second dispositions respectively.

In a preferred aspect of this embodiment, the apparatus comprises meansfor temporarily occluding drainage of fluid passing through the firststent from the anterior chamber into the subconjunctival space with thefirst stent implanted into the eye in the first disposition withoutoccluding drainage of fluid through the second stent.

In another preferred aspect of the first embodiment, the delivery meanscomprises a cannula having an anterior surface and a posterior surfaceand at least first and second channels for retaining the first andsecond stents respectively with a friction fit, wherein the cannulacomprises means for differentiating the anterior and posterior surfaces,and wherein the first stent and the second stent are disposed within thecannula in an anterior to posterior orientation.

In a further preferred aspect of this first embodiment, the first stentis disposed in the delivery means and is sized and configured forimplantation into the eye with the inflow end of the first stent in theanterior chamber and the outflow end of the first stent in thesubconjunctival space and the second stent is disposed in the deliverymeans and is sized and configured for implantation into the eye with theinflow end of the second stent in the anterior chamber and the outflowend of the second stent in Schlemm's canal.

In another preferred aspect of this first embodiment, the first stent isdisposed in the delivery means and is sized and configured forimplantation into the eye with the inflow end of the first stent in theanterior chamber and the outflow end of the first stent in thesubconjunctival space and wherein the second stent is disposed in thedelivery means and is sized and configured for implantation into the eyewith the inflow end of the second stent in the anterior chamber and theoutflow end of the second stent in the suprachoroidal space.

In yet another preferred aspect of the first embodiment, the first stentis disposed in the delivery means and is sized and configured forimplantation into the eye with the inflow end of the first stent in theanterior chamber and the outflow end of the first stent in Schlemm'scanal and wherein the second stent is disposed in the delivery means andis sized and configured for implantation into the eye with the inflowend of the second stent in the anterior chamber and the outflow end ofthe second stent in the suprachoroidal space.

In a still further preferred aspect of the first embodiment, theplurality of stents further comprises a third stent, the third stentbeing sized and configured for being implanted in the eye through a holein a third membrane separating the anterior chamber of the eye from athird anatomical space of lower pressure than the anterior chamber in athird disposition with an inlet end of the third stent in the anteriorchamber and an outlet end of the third stent in the third anatomicalspace to permit drainage of fluid from the anterior chamber to the thirdanatomical space and with a portion of the third stent engaging with athird membrane to stabilize and retain the third stent in the thirddisposition, the hole forming means comprising means for forming a holein the third membrane through which the third stent is insertable or thethird stent comprising a sharpened end for forming a hole in the thirdmembrane through which the third stent is insertable; the first, secondand third stents being disposed in the delivery means and being sizedand configured such that, when the delivery means is in the firstposition adjacent to the trabecular meshwork and an actuation force isapplied to each of the first, second and third stents, the first, secondand third stents are implantable into the eye in the first, second andthird dispositions respectively with the inflow end of the first stentin the anterior chamber and the outflow end of the first stent in thesubconjunctival space, with the inflow end of the second stent in theanterior chamber and the outflow end of the second stent in Schlemm'scanal and with an inflow end of the third stent in the anterior chamberand an outflow end of the third stent in the suprachoroidal space.

In accordance with yet another preferred aspect of this embodiment, theactuating means comprises a first mechanism comprising a first end witha first member that is slidable along a first surface of the cannulawhen pushed by a thumb or finger of a user, the first mechanism having asecond end with means for simultaneously pushing the first, second andthird stents out of their respective channels and implanting them intothe eye in the first, second and third dispositions respectively whenthe first slidable member is slid along the first surface toward thefirst, second and third stents.

In accordance with a second embodiment of the invention, there isprovided an apparatus for relieving intraocular pressure in an eye of asubject comprising a multi-sided body made of biocompatible materialsuitable for implanting into the eye, the body comprising opposing firstand second sides with the first side having at least one opening and thesecond side comprising an array of tubular projections projectingtherefrom, the at least one opening on the first side of the body beingin fluid communication with the array of projections projecting from thesecond side of the body, the body and the plurality of projections beingsized and configured such that the apparatus is insertable into theanterior chamber of the eye through a single incision and is implantableinto a position in the anterior chamber of the eye with the second sideof the body contacting the chamber angle of the eye and with eachprojection of the array of projections projecting into the chamber angleand into an anatomical space selected from the group consisting of asubconjunctival space, Schlemm's canal, a suprachoroidal space and acombination thereof so as to stabilize and retain the implant in theposition in the anterior chamber and to permit drainage of fluid fromthe anterior chamber into the selected anatomical space or spaces.

In a preferred aspect of this second embodiment, the apparatus comprisesmeans for delivering the body into the eye through a single incision inthe anterior chamber and for implanting the body into the position inthe anterior chamber with the second side of the body contacting thetrabecular meshwork. In one aspect, the delivery means comprises forcepswith a clamping mechanism for holding the body until the array ofprojections are implanted into the eye and a release mechanism forremote release of the clamping mechanism such that the forceps can bedelivered to the implantation site through an incision in the cornea andcan be released by an operator (surgeon) outside of the eye.

In accordance with a further preferred aspect of this embodiment, eachof the plurality of projections has a sharpened tip for penetrating inand through the trabecular meshwork. In another preferred embodiment,each of the projections in the array of projections has a conical shapeand projects from the second side of the body at an acute or obtuseangle.

In accordance with a still further preferred aspect of the secondembodiment, at least a subset of the array of projections projects intothe subconjunctival space and the apparatus comprises means fortemporarily occluding drainage of fluid passing through at least oneprojection in the subset of projections without occluding drainage offluid passing through one or more other projections in the array.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of the disclosure and are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosure,and together with the description serve to explain the principles of thedisclosure.

FIG. 1 illustrates a cross section of the anatomy of the anteriorchamber and preferred outflow channels.

FIGS. 2-4 illustrate exemplary stents or shunt valves that have beenused in the prior art to drain aqueous from the anterior chamber todifferent anatomical spaces to relieve the intraocular pressure in theanterior chamber.

FIG. 5 is an end view of an exemplary delivery vehicle comprising acannula for delivery of three (3) stents according to one embodiment ofthe present invention.

FIG. 6 illustrates an exemplary shunt tack embodiment of the inventionshowing delivery and implantation of the tack shunt into the anteriorchamber ab interno.

FIGS. 7A-G are perspective and side views of an exemplary shunt tackdevice according to one embodiment of the present invention.

FIGS. 8A-D are perspective views of exemplary shunt tack embodiments ofthe present invention.

FIG. 9 illustrates a shunt tack disposed within a cannula for deliveryinto the eye.

FIG. 10 is a schematic view of an exemplary inserter or actuator forcausing a plurality of stents to be simultaneously pushed from a cannulaand into an eye.

FIG. 11 illustrates an exemplary subconjunctival shunt with means forocclusion of the outflow pathway of the shunt.

FIG. 12 illustrates an exemplary deck for tri-flow drainage of aqueousfrom the anterior chamber according to one embodiment of the presentinvention.

FIG. 13 illustrates three (3) stents in situ after being implanted inseparate anatomical spaces in the eye according to one embodiment of thepresent invention.

FIG. 14 is a perspective view of a delivery vehicle releasably carryingthree (3) stents in respective tubular channels and an actuator forpushing the stents out of the channels according to one embodiment ofthe present invention.

FIGS. 15A-E illustrate exemplary delivery vehicles for simultaneousimplantation of three (3) stents into separate areas of a singleanatomical space according to one embodiment of the invention.

FIG. 16 is a cross sectional view showing respective subconjunctival,suprachoroidal, and trabecular stents in situ in the eye.

FIG. 17 is a perspective view of a forceps delivery vehicle forinsertion of a deck with an array of shunts into the eye.

FIG. 18 is a perspective view of a delivery vehicle for carrying three(3) stents inside channels, a guide wire and an actuator for causing thestents to be inserted into a single outflow pathway in an eye.

FIG. 19 shows forceps for use with a tack shunt embodiment of theinvention.

FIGS. 20A-C illustrate an exemplary shunt tack embodiment of theinvention with a single inflow opening and a mechanism for delivery ofthe shunt tack into the anterior chamber.

FIG. 21 illustrates a finger actuator for ab interno delivery of one ormore stents into an eye of a patient;

FIG. 22 shows the disposition of a cannula carrying a stent or pluralityof stents into the anterior chamber with actuator disposed outside ofthe eye for ab interno implantation of the stents.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to FIG. 1, therein is shown a simplified and diagrammaticillustration of the eye structure in the minimum detail to illustratethe invention in a clear fashion. The anterior aspect of the anteriorchamber 1 of the eye is the cornea 2 whereas the posterior aspect is theiris 4 beneath which is the lens 5. The anterior chamber 1 is filledwith aqueous humor 3. The aqueous humor 3 drains into thesubconjunctival space 6 through the trabecular meshwork 10 of the sclera8. The aqueous humor is drained from the subconjunctival space 6 througha venous drainage system (not shown). The subconjunctival space 6 isformed between the conjunctiva 7 and the sclera 8. Schlemm's canal 9 islocated peripheral to the trabecular meshwork 10. The suprachoroidalspace 11 is a space between the sclera 8 and the choroid 12, which isknown to provide a pathway for uveoscleral outflow. Below the choroid 12is the retina 13.

In conditions of glaucoma, the pressure of the aqueous humor in the eye(anterior chamber) increases and this resultant increase of pressure cancause damage to the vascular system at the back of the eye andespecially to the optic nerve. The treatment of primary glaucoma, andother diseases which lead to elevated pressure in the anterior chamber(secondary glaucoma), involves relieving pressure to a normal level.

FIGS. 2, 3 and 4 illustrate examples of stents or shunt valves 20, 30and 40 that have been used in the prior art to relieve the intraocularpressure in the anterior chamber by providing a flow path from theanterior chamber to the subconjunctival space (FIG. 2), Schlemm's canal(FIG. 3) and the suprachoroidal space (FIG. 4) respectively. FIG. 2shows a shunt valve 20 of the prior art comprising a tubular body havingan outer surface engaging the sclera with the valve implanted throughthe sclera with an inflow end of the valve in the anterior chamber andan outflow end of the valve in the subconjunctival space. FIG. 3 shows ashunt valve 30 of the prior art comprising a tubular body having anouter surface engaging the trabecular meshwork with the valve implantedthrough the trabecular mesh and into Schlemm's canal. FIG. 4 shows ashunt valve 40 of the prior art comprising a tubular body passingthrough the trabecular meshwork with the valve implanted in thesuprachoroidal space. The respective stents may be sized and configuredto engage the respective wall or membrane separating the anteriorchamber from the respective anatomical spaces in an installed position.Each of the valves 20, 30 and 40 has an axial bore extending completelythere through to establish communication between the anterior chamberand a respective one of the anatomical spaces with the valves in theinstalled position.

Unlike the prior art devices, each of which is implantable ab internofor providing an outflow pathway to a single anatomical space only, thedevices according to one embodiment of the invention are implantable abinterno and comprise a multiplicity of fluid outflow orifice means(ports) directed at a plurality of fluid (aqueous) outflow pathwayswithin the eye. In a preferred embodiment, the device comprises threeoutflow means for tri-flow of aqueous from the anterior chamber toSchlemm's canal, suprachoroidal bypass, and subconjunctival spacerespectively. In another embodiment, two outflow channels are providedfor dual- or bi-flow of aqueous to two anatomical spaces selected fromthe group consisting of (a) the subconjunctival space and Schlemm'scanal, (b) the subconjunctival space and the suprachoroidal space and(c) the suprachoroidal space and Schlemm's canal.

Referring to FIG. 5, therein is seen a cannula 50, a preferred deliveryvehicle of the invention, in which a plurality of stents 55, 56 and 57can be together delivered to a position within the anterior chamber ofan eye adjacent the trabecular meshwork for implantation of the stentsinto the subconjunctival space, Schlemm's canal and the suprachoroidalspace respectively. The cannula 50 contains an implant base 51comprising tubes or channels with lumens 52, 53, and 54 for carrying asubconjunctival stent 55, a suprachoroidal stent 56 and a canal stent 57that have been inserted into the respective lumens with a frictionalfit. The stents for insertion in the lumens of the respective channelscan be those depicted in FIGS. 2, 3, and 4 or any other stent(s) thatcan perform the desired function of draining aqueous from the anteriorchamber to the respective anatomical spaces, including stents that havebeen used in the prior art for insertion into the eye ab interno fordraining to each of the anatomical spaces individually. One or more ofthe stents may be loaded onto a guidewire 58 before insertion into theeye, and the guidewire may be used to locate the stent to the targetedspace. The guidewire 58 has a lumen of a size that is, by way ofexample, approximately 150 micron in diameter. The stent may be releasedfrom the guidewire when the guidewire has placed the stent at a desiredanatomical space in the eye. After the stent is released from thedelivery device, the guidewire can be retracted. FIG. 5 shows therelative diameters of the identified stents in a preferred embodiment ofthe invention, but the diameter of each stent 55, 56, and 57 could bemade larger or smaller.

The stents 55, 56 and 57 contain bores extending there through fordraining fluid from the anterior chamber to the respective anatomicalspaces. The outer surfaces of the respective stents may preferably beprovided with slots or other means for enhancing frictional engagementwith respective membranes through which they are inserted. The thicknessof the slots can be such as to enable the stents to engage therespective membranes through which they are inserted to maintain thestents in a secure position against fore and aft movement so that theopen ends of the tubular body will respectively communicate with theanterior chamber and the respective anatomical spaces for allowing flowof aqueous fluid from the anterior chamber to the respective anatomicalspaces.

The geometry of the base can be such as to provide an indication of therespective orientation of the stents in the cannula 50. For example, inFIG. 5 the top 59A of the implant base is flat whereas the bottom 59B ofthe implant base is rounded.

The stents or shunt valves can be made of a conventional plasticmaterial such as polymethyl methacrylate, silicone or the like. Thevalves can also be made of a hydrophilic substance which will swell uponcontact with the aqueous humor. Known hydrogels serve this function.Surgical steel, titanium and other non-reactive metals or alloys whichare biocompatible may be used for this purpose. The valve can also bemade of a material which slowly dissolves in the aqueous humor, such ascollagens, and they can contain medications such as anti-inflammatory,anti-thrombotic, anti-scarring, anti-cross-linking and immunosuppressive agents.

The composition of the material of the valve shunts or stents and theirdimensions can be selected to provide a certain amount of flexibilityfor the valves allowing them to deform elastically, for example, to anarcuate shape, to facilitate installation into an anatomical space. Thevalves can return to their initial position after such elasticdeformation. All or a portion of a valve shunt may be naturally curvedto conform to the curvature of the globe of the eye or otherwise tofacilitate insertion of the valve shunt, particularly when the valveshunt is targeted for delivery to the subconjunctival and suprachoroidalspace.

Referring to FIG. 5, the respective stents are disposed in the cannulato facilitate their implantation in the eye in respective dispositionsthat enable drainage of aqueous from the anterior chamber to therespective anatomical spaces. In this connection, the subconjunctivalstent 55 and the canal stent 57 are disposed in the cannula 50 closer tothe anterior surface of the cannula than the suprachoroidal stent 56.The cannula is preferably circular or ovoid in shape with an outerdiameter of 1000 to 1500 μm. The subconjunctival stent preferably has anouter diameter of 150 to 400 μm with a lumen of its tubular body between10-150 μm. The trabecular meshwork/Schlemm's canal stent preferably hasan outer diameter of 200 to 400 μm and a lumen of its tubular body ofbetween 70-150 μm. The suprachoroidal stent preferably has an outerdiameter of 300 to 500 μm and a thickness a lumen of its tubular bodybetween 100-200 μm.

FIG. 14 shows a perspective view of a cannula similar to that shown inFIG. 5. FIG. 14 depicts a cannula 50 comprising tubular channels 144,145, and 146 with sharpened edges at tips 144A, 145A, and 146A of eachchannel carrying subconjunctival stent 141, trabecularmeshwork/Schlemm's canal stent 142 and suprachoroidal stent 143releasably contained in the channels with a friction fit. As shown inFIG. 14, channels 144, 145, and 146 can be provided with sharpened ends144A, 145A, and 146A for forming holes in respective membranes of theeye through which the stents can pass when implanted. The channels 144,145 and 146 are of respective lengths sufficient to deliver therespective stents contained therein to the respective anatomical spacesfor which they are targeted. Plunger 147 is provided with prongs 200,202 and 204 to push the respective stents out of cannula 50, through theholes formed by the sharpened ends of the channels and into targetedspaces in the eye. The respective lengths and dispositions of the stentsand prongs are selected to insure implantation of the stents with theirrespective outflow ends in the respective anatomical spaces for whichthey are targeted. Preferably, the subconjunctival stent 141 will have alength of between 6 to 9 mm; the suprachoroidal stent 143 will have alength of between 4 to 7 mm; and the canal stent 142 will have a lengthof between 3 to 8 mm. The stents 55, 56, and 57 can be deliveredsimultaneously with plunger 147. FIG. 13 shows the stents 55, 56 and 57delivered into respective anatomical spaces in the eye.

FIG. 14 shows one plunger 147 for use in simultaneously implanting thethree stents 55, 56, and 57. It may be appreciated, however, that in analternative embodiment one plunger can be used to deliver two of thestents simultaneously and a separate plunger can be used to deliver thethird stent. It is also possible to provide three (3) separate plungersfor implantation of each of the three stents separately. FIG. 21provides an example of a finger actuator that may be used to deliver asingle stent. It can also be adapted to deliver two (2) or three (3)stents.

In FIG. 21, delivery apparatus 440 comprises a cannula 448 carryingstent 444 at one end thereof. A handle 450 is provided at the oppositeend of cannula 448. A finger actuator 442 is also provided which isattached to plunger body 446 and plunger end 452. The finger actuator442 can be advanced along a slot in the cannula in the direction of thearrow for exerting a force on the end of stent 444, which can be used topush stent 444 into the eye for implantation in a targeted space. Stent444 has a sharpened tip which can facilitate formation of a hole in thetissue of the eye. Although not drawn to scale, it may be appreciatedthat the cannula has sufficient length to extend from the outside of thecornea of an eye to the targeted location with the handle and fingeractuator also outside of the eye where they can be manipulated by asurgeon.

Referring now to FIG. 10, there is seen a preferred mechanism 100 forimplanting stents simultaneously in another embodiment of the invention.FIG. 10 shows a bi-flow embodiment for implantation of two (2) stents, asoft stent 107 for implantation, for example, in the trabecularmeshwork/Schlemm's canal and a rigid stent 108 for implantation, forexample, in the suprachoroidal space. Stent 107 is carried in tubularchannel 111 of cannula 50 whereas stent 108 is carried in tubularchannel 109 of cannula 50. Since stent 108 is rigid, like thosecommercially available as the iStent® or CyPass®, the stent itself canbe provided with puncturing means (e.g., a needle-like or blunt tip) forforming a hole in tissue of the eye through which the stent can bepushed. With a soft stent, such as stent 107, tubular channel 111 can bein the form of a needle with sharpened tip 110 for forming a hole intissue through which the stent can then be pushed for implantation.

FIG. 10 shows alternative mechanisms by which stents 107 and 108 can beadvanced out of their respective channels and into respective anatomicalspaces in the eye. In a first mechanism, after cannula 50 is insertedinto the eye with an end in the anterior chamber adjacent the trabecularmeshwork, a force can be exerted against plunger 106B, crosspiece 105,prongs 112 and 113 and end pieces 103 and 104 to push stents 107 and 108out of their respective channels. In a second mechanism, a slide piece106A connected to crosspiece 10, prongs 112 and 113 can be provided forsliding through a slot in the cannula (not shown) to push the stents outof their respective channels. Although FIG. 10 is not drawn to scale, itmay be readily appreciated that the cannula 50 and the respectiveplunger mechanisms can be dimensioned for ab interno implantation intothe eye of a patient. Thus, a first end of the cannula carrying stents107 and 108 can be inserted into the anterior chamber through anincision in the cornea that is remote from the implantation site suchthat the stents are disposed adjacent the trabecular meshwork with theplungers 106A and 106B projecting outside of the site of the cornealincision. With that disposition, either plunger 106B or slide piece 106Acan be actuated by the hand of an operator (surgeon) from outside of theeye to push the stents out of their respective channels.

Still referring to FIG. 10, the individual plungers can be disposed atdifferent distances from the stents for use with stents of differentlengths. Thus, a shorter stent 107 (e.g., a stent targeted for thetrabecular meshwork/Schlemm's canal) could be delivered after a longerstent 108 (e.g., a stent targeted for the suprachoroidal space) isalready advanced to penetrate a target tissue. The shorter stent 107could be placed in its channel but not delivered until the individualplunger 103 delivers the longer stent 108 first. For example, in atri-flow embodiment, if a slide mechanism delivers a XEN® stent, CyPass®stent, and an iStent® stent and the XEN® stent is longer than theCyPass® stent, which is longer than the iStent®, the XEN® could bedelivered first, the CyPass® next, and the iStent® last. While only twostents are shown in FIG. 10, it will be appreciated that three stents(i.e., the tri-flow embodiment) can be advanced using a similar slidemechanism.

Referring to FIGS. 15A-E, there can be seen other exemplary deliveryvehicles of the invention. FIGS. 15 A and B each depicts three (3)stents 308, 309, and 310 with sharpened tips disposed in cannula 50 fordelivery of the stents into different areas of a single anatomicalspace, i.e., different areas of the subconjunctival space, Schlemm'scanal or the suprachoroidal space. FIG. 15E comprises three stents 300,301, and 302 carried in respective channels 305, 306, 307 of a deliveryvehicle 310 and a plunger 151 for simultaneously pushing the threestents out of their respective channels until their outflow ends are alldisposed in a single one of the preferred anatomical spaces, e.g., inthe subconjunctival space, in the suprachoroidal space or in Schlemm'scanal. As shown in FIG. 15E, the stents may preferably be provided withsharpened tips 153 for forming holes in eye tissue through which thestents can pass, although this is not necessary in this or the otherembodiments since stents with blunt ends can also be used to form holesin the tissue of the trabecular meshwork. Unlike the other embodimentsdescribed above, in this embodiment of the invention, plunger 151 placesthe stents simultaneously in one of the outflow pathways, i.e., thetrabecular meshwork/Schlemm's canal, or suprachoroidal space, or thesubconjunctival space. In contrast, FIG. 15C shows stents 162 and 164disposed in channel guide 160 wherein a separate plunger 152 is providedfor pushing stent 162 out of the channel guide. Another plunger (notshown) can be provided for separate insertion of stent 164.

Referring to FIG. 18, there is shown another preferred delivery vehicleof the invention, which is analogous to that shown in FIGS. 15A-F.Actuator or hand piece 181 is shown disposed in the cannula for applyinga force to the proximal ends 182A, 183A and 184A of the stents to causethem to be released from the cannula and implanted in the eye of apatient. Actuator 181 is depicted in the figure as having a base 181Dwith three (3) prongs 181A, 181B, and 181C. The prongs have ends whichare respectively configured and dimensioned to fit within the channels185, 186, and 187 and to contact the proximal ends 182A, 183A, and 184Aof the stents to apply a suitable force thereto to cause simultaneousrelease and implantation of the stents when a corresponding force isapplied to move the base 181D, either manually or by mechanical means.

FIG. 22 depicts the disposition of the delivery means, cannula 600 withchannels 610, 612 and 614 carrying a plurality of stents 604, 606 and608 in the tri-flow embodiment when the plurality of stents are beinginstalled ab interno. The entry site of the delivery means carrying thestents is made through an incision at a location 616 remote from thesite 618 adjacent to the trabecular meshwork at which the delivery meansdelivers the stents. Once a tip of the cannula is apposite thetrabecular meshwork, the operator (surgeon) pushes or otherwiseactivates the actuator to push the stents through the trabecularmeshwork and, in the case of the subconjunctival stent, through thesclera, and into the respective outflow channels where they are securedby friction. FIG. 16 is a schematic diagram showing the outflow ends ofthe respective subconjunctival, canal and suprachoroidal stents 141, 142and 143 when implanted in the eye.

Reference is now made to FIG. 7A-G, which show another embodiment of theinvention in which a multi-sided deck or platform 70 has an array ofshunts 71 integrated therein. The deck has first side 73 and second side72. The array of shunts project from the second side 72 of the deck orplatform only and are disposed to secure the deck to an inside surfaceof the trabecular meshwork by friction with the second side of the deckcontacting the trabecular meshwork and the stunts in the arrayprojecting through the trabecular mesh to the subconjunctival space,Schlemm's canal and/or the suprachoroidal space. See FIG. 6. Themultiple shunts are preferably integral to the deck and are “stuck” intothe trabecular meshwork and other structures of the eye in a manner thatis analogous to the manner in which “tackless” wooden corner pieces areused to secure wall-to-wall carpeting. The shunts 71 projecting from thesecond side 72 are in fluid communication with the openings 74 in thefirst side 73 of the deck such that, with the deck secured to thetrabecular meshwork and the stunts projecting through the trabecularmeshwork to the subconjunctival space, Schlemm's canal and/or thesuprachoroidal space, fluid can be drained from the anterior chamber toan anatomical space or spaces of lower pressure. The lumen size of theshunts 71 can be constant or variable, e.g., tapered to a point 75 so asto readily penetrate target tissues. Some or all of the shunts 71 can betemporarily occluded. The multiplicity of the shunts 71 and points wouldhold the device shown in FIGS. 7A-G securely in the eye.

For optimal stabilization of the device in the eye, the shunts arepreferably disposed with respect to the deck at an acute and/or obtuseangle and are preferably tapered and of generally conical shape,although other shapes and orientations would work so long as they canperform the function of securing or stabilizing the device in the eye.Thus, the deck 70 may be of rectangular, circular or other shape, andthe stents may be arranged on the second side of the deck in a pluralityof rows or circumferentially so long as there are sufficient stents tosecure the deck in the eye, preferably at least four (4), morepreferably at least six (6), and most preferably at least eight (8).Preferred arrangements of the stunts 71 on deck 70 are shown in FIGS.7A-G, FIG. 8 and FIG. 17. The distal ends of the projecting shunts 71preferably have openings with a diameter of about 5 μm and proximal endswith openings of about 10 μm. The body of a rectangular deck willpreferably be about 100 to 500 μm. The body of a circular deck willpreferably be about 300 μm in diameter.

Referring to FIGS. 8A-D, there are seen exemplary deck devices accordingto other embodiments of the invention. The deck 81 in the embodiment ofFIG. 8A is a flat round disk with the tacks posterior. The deck 82 inthe embodiment of FIG. 8B is a rounded disk with a depression 85 to thinthe material with the tacks posterior (see FIG. 8C). The deck 83 in theembodiment of FIG. 8D is of rectangular shape. The cross-action forcepsdescribed below can be used for any of the shunt tack embodiments.Alternatively, a small plunger could be used centrally in the deck 82 ofFIG. 8B to push the disk into position using a cannula. FIG. 9 shows ashunt tack 103 disposed with a friction fit in cannula 104 which can beused in this regard.

Referring now to FIG. 12, there is shown a further embodiment of theinvention wherein a block 120 of biocompatible material in provided withthree stents 121, 122, and 123 embedded therein and with ends of thestents projecting therefrom. Although a generally rectangular block isshown, the block can be of any shape, including oblong, round, ovoid orsquare. In FIG. 12, the small opening 123 can be disposed for targetingto the subconjunctival space (in the manner of e.g., XEN®), the middleopening 122 can be disposed for targeting to the trabecularmeshwork/Schlenun's canal (in the manner of, e.g., iStent®), and thelargest opening 121 can be disposed for targeting to the suprachoroidalspace (in the manner of, e.g., CyPass®). The individual stents 121, 122,and 123 may be provided with pointed or blunt tips for entering targettissues. Block 120 can be implanted in the eye adjacent the trabecularmeshwork with the stents projecting through the trabecular meshwork withthe respective ends of the stents disposed in the respective targetspaces. Block 120 can be delivered into the anterior chamber inside of acannula that has indicia indicating anterior/posterior location or itcan be delivered with a holding/locking forceps that would deliver it tothe target location without the use of a cannula. The forceps can bereleased once the block 120 is secured in the eye.

Referring to FIGS. 20A-C, there is shown an embodiment that is similarto that shown in FIG. 12, wherein a deck 304 is provided with stents 306embedded therein with portions 306 projecting therefrom. The projectingportions 306 of the stents should be of sufficient length such that theoutflow ends of the projecting portions are disposed in the targetedanatomical space or spaces for draining aqueous from the anteriorchamber. Deck 304 can be provided with a single opening 320 for drainageof aqueous from the anterior chamber through the stents 306, as shown inFIG. 20A, or it can be provided with multiple openings 322, 324 and 326for drainage of aqueous through the stents 306, as shown in FIG. 20B.FIG. 20C shows U shape ends of cross action forceps 330 that may be usedto grasp and deliver the deck for implantation into the eye.

FIG. 6 shows the disposition of the deck 80 and forceps when the deviceis being installed in the eye ab interno. In FIG. 6, the deck 80 isdisposed in the trabecular meshwork. The entry site of the deliverymeans carrying the stents is made through an incision 61 at a locationremote from the site 62 adjacent the trabecular meshwork at which theforceps delivers the device. Once the deck is secured with the shuntsprojecting through the trabecular mesh and into the subconjunctivalspace, Schlemm's canal and/or suprachoroidal space, the forceps isreleased and removed from the eye. Reference numerals 84 and 86 showshunt tacks that have already been implanted. A shunt tack can also beplaced in a cannula using forceps. If the shunt tack is made in a roundor ovoid shape, then using a cannula might be more convenient, but asquare or ovoid needle/cannula can also accommodate a rectilinear shunttack.

FIG. 17 shows an implantable deck or body 176 with projecting stentsreleasably fit within a holding or delivery means, which in the figurecomprise forceps 172 having a pair of pincers or tongs for securing thedeck until it is positioned in the anterior chamber with the shunts orstents introduced into their appropriate outflow channel(s). The forcepscan be used to insert the deck through an incision in the cornea that isremote from the site in which the deck is implanted into an eye. FIG. 17shows reverse action forceps 172, which can hold the shunt tack device176 until opposing ends 174 and 176 of the forceps are squeezed therebyreleasing pincers 178 and 180 from the device once the device isimplanted. FIG. 17 is not drawn to scale but it may be appreciated that,for ab interno insertion, the distance from screw hinge 181 to holdingpart 183 of the forceps should be longer than an inside of the cornealdiameter of 13 mm, e.g. about 15 mm, and the hinge should be outside ofthe eye with the squeeze portion of the forceps preferably about 3-4″long. FIG. 19 shows exemplary cross action forceps 500 that can be usedto deliver and implant the deck in another embodiment. Forceps 500 has afirst end with pincers 501 and 502 that can be used to clamp on the bodyof a tack shunt 503 and a cross action mechanism that can move thepincers from a clamped position to a release position when ends 504 and505 of the forceps are squeezed. The ends 504 and 505 of the forceps canbe squeezed from outside of the eye to release the forceps from theclamped position and the forceps can then be withdrawn through theremote incision in the cornea with the tack shunt implanted in the eye.

Each of the embodiments of the invention may comprise means forpreferential occlusion of drainage into one of the anatomical spaces,preferably the subconjunctival space, on a temporary basis. Inflammationis believed to be the issue in failure for most glaucoma surgeries thatdrain into the subconjunctival space (Trabeculectomy, Tube ShuntDrainage Devices, XEN). These drainage sites have been demonstrated tohave pro inflammatory molecules called cytokines coming from the aqueousin the anterior chamber. It has been shown that, by reducing the flow ofcytokines into the subconjunctival space by closing off the aqueousdrainage for a period of time, the procedures are more successful. Apreferred way of doing this is temporarily to close off the shunts oropenings by occluding them. A problem with this is IOP increases postoperatively and, when the occlusion stops, very low IOP can causebleeding into the eye. With the use of shunts of the invention havingmultiple outflow pathways, this problem can be alleviated bypreferentially closing off one or more of the pathways, e.g., a pathwayor pathways to the subconjunctival space, without closing off other ofthe pathways whereby to allow drainage through the other pathways.

Means for temporary occlusion of individual pathways are well known inthe art and include, by way of example: sponges with occlusion frombiodegradable coatings, biodegradable polymers withanti-inflammatory/anti-infectious properties and sponges acting asshunts in the subconjunctival space. The use of sponges withbiodegradable coatings and biodegradable polymers withanti-inflammatory/anti-infectious properties are described, for example,in U.S. Pat. No. 7,655,831 to Prywes and U.S. Pat. No. 5,346,464 toCamras, which are incorporated herein by reference. The use of a spongeas a stent which occludes flow of aqueous from the anterior chamber tothe subconjunctival space is described in the inventor's U.S. Pat. No.7,655,831, the entire contents of which are incorporated herein byreference. The sponge is constructed and arranged to occlude flow ofaqueous from the anterior chamber to the subconjunctival space until apressure in the anterior chamber increases to force the fluid throughthe sponge into the subconjunctival space. FIG. 11 shows a stent 363engaged with membrane 362 having a sponge 360 occluding an end 364 ofthe stent. In another preferred aspect of the first embodiment of thepresent invention, a sponge can be used as the stent that is implantedfor drainage of aqueous from the anterior chamber into thesubconjunctival space.

A preferred method of installation of the shunt valves or stents of theinvention is that the valves are engaged with the trabecular meshworkand/or sclera in the direction from within the anterior chamber to thesubconjunctival space, the entry site of the valves and delivery toolbeing made at a location remote from the site at which the valve isimplanted in the sclera. Specifically, a small incision is made in thecornea to permit insertion of the valves and the delivery tool into theinterior of the anterior chamber. Installation of the valve into therespective membrane or wall therefore, takes place from within the eye.Prior to insertion of the valves and a delivery instrument into theanterior chamber, a viscoelastic fluid is injected into the anteriorchamber to prevent collapse of the anterior chamber. A saline solutionmay be injected into the anatomical space to inflate the space and forma “bleb.” The delivery instrument with the valves externally mounted onits end is then inserted, valve-first, through the incision in thecornea. The instrument may be inserted substantially parallel to theiris to avoid contact with the corneal endothelium. When the instrumentis located in a position adjacent the trabecular meshwork, the operator(surgeon) activates the cutting means, by for example pushing a cannulahaving respective channels with sharpened tips, to form respective holesin a membrane or membranes through which the respective valves may thenbe advanced through the respective holes to position their ends in therespective anatomical spaces. The lumens of the membrane or membranesthough which the valves are advanced have sufficient flexibility toallow the valves to penetrate into the holes and, when the valve hasbeen advanced a sufficient distance, the membrane(s) will elasticallyengage the valves so that they are elastically retained. When the valveshave been implanted, the delivery instrument is withdrawn and removedthrough the incision in the cornea.

After the valves have been implanted and the instrument has beenremoved, a suture may (optionally) be placed to close the incision.Since the incision is distant from the implant site, there is minimumtrauma to the eye at the implant site.

Although the invention has been described with reference to thepreferred method of installation of the shunt valve in the directionfrom the anterior chamber to the subconjunctival space, it is alsopossible to implant the valve in the sclera working from outside the eyethrough the subconjunctival space into the anterior chamber. In thisvariation of the invention, an initial incision is made in the eye at alocation distant from the implant site of the valve, and the deliveryinstrument with the valves thereon is introduced through the incision tobring the end of the tool into proximity with the membranes at thelocation where the hole is to be formed. The valves will then bedisposed on or in the instrument in a reversed position from how theyare disposed for insertion ab interno. As in the ab interno embodiment,the instrument forms the hole in the sclera where after the valves areinserted into the formed holes and engage with the respective membranes.After the valves have been implanted, the delivery instrument iswithdrawn.

The method of installation according to the ab interno approach ispreferred insofar as the valves may be implanted and retained in placewithout any sutures and with the formation only of a small incisiondistant from the implant sites. The valves are inserted with the sameinstrument that forms the hole in the elastic membranes. The valves canbe made as one piece and installed in a single step surgical operationor it can be a two-piece unit with a subsequently added module in atwo-step operation.

While the invention has been described with reference to preferredembodiments thereof it will be apparent to those skilled in the art thatnumerous modifications and variations can be made within the scope andspirit of the invention as defined in the attached claims.

1-11. (canceled)
 12. An apparatus for relieving intraocular pressure inan eye of a subject, the apparatus comprising a multi-sided body made ofbiocompatible material suitable for implanting into the eye, the bodycomprising opposing first and second sides with the first side having atleast one opening and the second side comprising an array of tubularprojections projecting therefrom, the at least one opening on the firstside of the body being in fluid communication with the array ofprojections projecting from the second side of the body, the body andthe plurality of projections being sized and configured such that theapparatus is insertable into the anterior chamber of the eye through asingle incision and is implantable into a position in the anteriorchamber of the eye with the second side of the body contacting atrabecular meshwork of the eye and with each projection of the array ofprojections projecting through the trabecular meshwork and into ananatomical space selected from the group consisting of a subconjunctivalspace, Schlemm's canal, a suprachoroidal space and a combination thereofso as to stabilize and retain the implant in the position in theanterior chamber and to permit drainage of fluid from the anteriorchamber into the anatomical space.
 13. The apparatus according to claim12, comprising means for delivering the body into the eye through asingle incision in the anterior chamber and for implanting the body intothe position in the anterior chamber.
 14. The apparatus according toclaim 13, wherein the means comprises forceps.
 15. The apparatusaccording to claim 13, wherein each projection in the array ofprojections has a sharpened tip for penetrating in and through thetrabecular meshwork.
 16. The apparatus according to claim 15, whereineach projection in the array of projections has a conical shape andprojects from the second side of the body at an acute or obtuse angle.17. The apparatus according to claim 13, wherein at least a subset ofthe array of projections projects into the subconjunctival space and theapparatus comprises means for temporarily occluding drainage of fluidpassing through at least one projection in the subset of projectionswithout occluding drainage of fluid passing through other projections inthe array.
 18. The apparatus according to claim 17, wherein at least afirst projection in the array of projections projects into thesubconjunctival space, at least a second projection in the array ofprojections projects into the suprachoroidal space and at least a thirdprojection in the array of projections projects into Schlemm's canal.19. (canceled)
 20. A method for relieving intraocular pressure in an eyeof a subject comprising the steps of: (a) providing the apparatus ofclaim 13; (b) inserting a first end of the delivery means carrying theapparatus through a single incision in the cornea of the eye to aposition in the anterior chamber of the eye that is adjacent thetrabecular meshwork; and (c) implanting the apparatus into a position inthe anterior chamber of the eye with the second side of the bodycontacting a trabecular meshwork of the eye and with each projection ofthe array of projections projecting through the trabecular meshwork andinto an anatomical space selected from the group consisting of asubconjunctival space, Schlemm's canal, a suprachoroidal space and acombination thereof so as to stabilize and retain the implant in theposition in the anterior chamber and to permit drainage of fluid fromthe anterior chamber into the anatomical space.